The government has invited public comments on the draft notification issued on Saturday. The notification will be finalised after considering the public comments received within seven days-Jan 11.”Provided that the-small and medium manufacturers with turnover of or less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the CentralLicenceApproving Authority within a period of three months from the date of publication of this notification along with the plan of upgradation. For such manufacturers the timeline for implementation shall be extended till 31″ December, 2025,” it said
On Friday ET had reported that Nearly half of the estimated 10,000 drug manufacturing units in the country may not be able to meet the deadline for upgrading their facilities as per the revised Schedule M of the Drugs and Cosmetics Act, according to industry executives, making them vulnerable to potential closure.
Schedule M, which outlines quality standards for pharmaceutical products, was notified by the health ministry in January last year.
The industry had been seeking a two-year extension for improving infrastructure, additional manpower recruitment and training.
Industry leaders had earlier met the health minister and sought an extension, citing problems like delay in procurement of machinery and update of infrastructure. The industry said it needs more time to ensure survival of micro, small and medium enterprises (MSMEs).
However the government on Saturday came out with a new notification giving a year’s extension to the pharma industry.
The industry will have to comply with the newly notified Schedule M norms for manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products, with provisions for annual product quality review (PQR), quality risk management (QRM), and pharmaceutical quality system (PQM).
Former DoP secretary Arunish Chawla had earlier told ET that adequate hand-holding is being done by the government.
“We have liberalised our scheme to specifically help the MSME upgrade their quality standards to revised Schedule M. That is progressing well. Recently we have liberalised it even further to ensure that the entire quality system, which includes the utilities, the testing laboratories, the stability chambers, the quality assessment systems as well as the core production system-the entire chain of production-top quality is included in the scheme,” he had said. “The industry has come forward to welcome this scheme with open arms and many of them have registered under the scheme to upgrade and some of them have already submitted their gap analysis. Dozens of them have already cleared the technical committee and they are being assisted to achieve global quality standards-the revised Schedule M and also the WHO GMP standards.”
